Anorexia Nervosa, Constipation
Conditions
Keywords
Probiotics, Anorexia nervosa, Constipation, Body weight
Brief summary
The aim of this study is to investigate whether Lactobacillus reuteri could have a beneficial role in treatment of children and adolescents with Anorexia nervosa who develop motility disorder due to the malnutrition regarding the normalization of the motility, as well as the possible role of probiotics on nutritional recovery, especially on bone health.
Detailed description
Pediatric patients with AN and constipation referred to gastroenterologist for nutritional rehabilitation at the Department of Pediatric Gastroenterology, Hepatology and Nutrition, Clinical Hospital Center Sestre Milosrdnice, Zagreb, approximately 30 children, will be asked to participate. The evaluation of patients will be conducted through APA DSM-V diagnostic criteria for anorexia nervosa and Rome III criteria for constipation. During the hospitalization all of the patients will receive conventional nutritional rehabilitation that is composed of serving normal food under supervision of nurses that calculate daily caloric intake through 5-6 meals and according to that additional enteral nutrition that consist of polymeric enteral formula. Daily caloric intake is calculated as kcal/kg/day and is slowly rising through 2 weeks starting from 80% to the goal of 130% of daily energy requirements according to FAO 2004 recommendation. Anthropometry measures will be taken at the time of hospitalization and at every visit. Normalization of weight is when the Z-score for BMI is less than -1.5 according to CDC BMI-growth charts, or normalisation of menstrual cycle is achieved. In order to achieve adherence to therapeutic protocol parents will be contacted by phone at least once in 7-10 days. Participants will be instructed to keep diary on a daily basis (adherence to therapy, stool diary). All patients will return packages with all used, and unused product. BASELINE -VISIT 1 Randomization at first day of hospitalization. In all patients anthropometry will be performed at the time of hospitalization, as well as dual-energy X-ray absorptiometry (DEXA) and serum D3 levels at first 2 days of hospitalization as a part of routine diagnostic protocol in heavily underweight patients with AN. VISIT 2 4 weeks after randomization, at discharge from hospital Anthropometry VISIT 3 8 weeks after randomization, 4 weeks after discharge from hospital Anthropometry END OF STUDY -VISIT 4 3 months after baseline Anthropometry VISIT 5 3 months after the end of study (6 months after baseline) At this point control serum D3 levels and DEXA will be performed at all patients Anthropometry All the symptoms and daily caloric intake will be monitored using diaries attached to protocol.
Interventions
DIETARY_SUPPLEMENTLactobacillus reuteri Protectis DSM17938
One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.
Sponsors
BioGaia AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
8 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric patients with Anorexia nervosa and constipation, aged 8-18 years
Exclusion criteria
* AN and constipation present for less than 3 month prior to hospitalization * any disease that affects GI or other systems other than AN or functional constipation * chronic disorder other than AN * receiving probiotic and/or prebiotic products 14 days prior to enrolment * receiving antibiotics 14 days prior to enrolment * constipation prior AN * receiving laxative as a therapy for constipation or abuse of laxative to lose weight prior to enrolment * extraintestinal symptoms: fever, rash * abnormalities in laboratory findings * abnormalities in clinical findings: organomegaly, perianal disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants That Drop Out From Rome III Criteria for Constipation | 3 month | Drop out from Rome III criteria for constipation: Yes / No. According to Rome III, a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on \>25% of defecations; b) lumpy or hard stools on \>25% of defecations; c) sensation of incomplete evacuation on \>25% of defecations; d) sensation of anorectal obstruction/blockage on \>25% of defecations; e) manual maneuvers on \>25% of defecations; and f) less than 3 defecations per week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Normalization of Body Weight | 6 month | normalization of body weight- 90% of premorbid weight, or ≥10. centile for BMI (according to the WHO growth charts) |
Countries
Croatia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lactobacillus Reuteri Protectis DSM17938 One chewable tablet twice per day with L reuteri Protectis DSM 17938, 1x108 CFU/tablet (colony forming unit)
Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months. | 15 |
| Placebo One chewable tablet twice per day with placebo per day
Lactobacillus reuteri Protectis DSM17938: One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months. | 16 |
| Total | 31 |
Baseline characteristics
| Characteristic | Placebo | Total | Lactobacillus Reuteri Protectis DSM17938 |
|---|---|---|---|
| Age, Categorical <=18 years | 16 Participants | 31 Participants | 15 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 15.13 years STANDARD_DEVIATION 1.7 | 15.06 years STANDARD_DEVIATION 1.96 | 15.06 years STANDARD_DEVIATION 2.31 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Croatia | 16 participants | 31 participants | 15 participants |
| Sex: Female, Male Female | 16 Participants | 31 Participants | 15 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 16 |
| other Total, other adverse events | 0 / 15 | 0 / 16 |
| serious Total, serious adverse events | 0 / 15 | 0 / 16 |
Outcome results
Primary
Number of Participants That Drop Out From Rome III Criteria for Constipation
Drop out from Rome III criteria for constipation: Yes / No. According to Rome III, a diagnosis of functional constipation is made when at least two of the following criteria are met for the last 3 months with symptom onset at least 6 months prior to diagnosis: a) straining on \>25% of defecations; b) lumpy or hard stools on \>25% of defecations; c) sensation of incomplete evacuation on \>25% of defecations; d) sensation of anorectal obstruction/blockage on \>25% of defecations; e) manual maneuvers on \>25% of defecations; and f) less than 3 defecations per week.
Time frame: 3 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactobacillus Reuteri Protectis DSM17938 | Number of Participants That Drop Out From Rome III Criteria for Constipation | 13 Participants |
| Placebo | Number of Participants That Drop Out From Rome III Criteria for Constipation | 10 Participants |
Secondary
Normalization of Body Weight
normalization of body weight- 90% of premorbid weight, or ≥10. centile for BMI (according to the WHO growth charts)
Time frame: 6 month
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lactobacillus Reuteri Protectis DSM17938 | Normalization of Body Weight | 14 Participants |
| Placebo | Normalization of Body Weight | 10 Participants |